In vitro method for the diagnosis and surveillance of cancer

Abstract

The present invention relates to an in vitro method for the diagnosis and/or the monitoring and/or predicting the progress of a cancer disease, characterized in that in at least one sample the ratio of Tregs-cells to at least one other group of T cells comprising the group of Th17 cells, Th1 cells and/or Th2 cells is determined.

1 . An in vitro method for the diagnosis, monitoring and/or prediction of the progress of a cancer disease in a test subject, said method comprising the step of determining in at least one test subject sample the ratio of Tregs-cells to at least one other group of T cells comprising the group of Th17 cells, Th1 cells and/or Th2 cells. 
     
     
         2 . The in vitro method according to  claim 1  characterized in that for the determination of the ratio of the Treg cells to the other group of T cells the Th17 cells, the Th1 cells and the Th2 cells are considered as a single group. 
     
     
         3 . The in vitro method according to  claim 1 , wherein the diagnosis is used for the stratification of patients into specific risk groups. 
     
     
         4 . The in vitro method according to  claim 1 , characterized in that the ratio of Tregs cells to Th17 cells is determined. 
     
     
         5 . The in vitro method according to  claim 1 , characterized in that the sample is derived from a tumor or a cell culture derived from a tumor. 
     
     
         6 . The in vitro method according to characterized in that the sample is a biopsy specimen of a tumor. 
     
     
         7 . The in vitro method according to  claim 1 , characterized in that the sample is an ovarian cancer sample. 
     
     
         8 . The in vitro method according to  claim 1 , characterized in that the ratio of the Treg cells is determined by flow cytometry analysis. 
     
     
         9 . The in vitro method according to  claim 8 , characterized in that the flow cytometry analysis of the Tregs cells is performed by surface staining with at least one of the antibodies selected from the group consisting of anti-CD3, anti-CD4, anti-CD8, anti-CD25, anti-CD 127, anti-CR4, anti-FoxP3 and anti-Helios. 
     
     
         10 . The in vitro method according to  claim 1 , characterized in that the ratio of the Treg cells compared with other T cells is determined by ELISA. 
     
     
         11 . The in vitro method according to  claim 1 , characterized in that the percentage of Treg cells is determined by real time PCR. 
     
     
         12 . The in vitro method for the diagnosis, monitoring and/or prediction of the progress of a cancer disease according to  claim 1  in a test subject, said method comprising the steps of:
 a. measuring the population of Tregs cells and at least one other group of T cells selected from the group consisting of Th17 cells, Th1 cells and/or Th2 cells in a sample obtained from said test subject; 
 b. determining the ratio of the population of said Tregs cells to the population of said at least one other group of T cells measured in step (a); and 
 c. comparing the ratio determined in step (b) to a pre-determined baseline threshold, wherein a measured differential is indicative of cancer. 
 
     
     
         13 . The in vitro method according to  claim 12 , further comprising the step (d) of classifying said test subject into a specific cancer stage or risk group based on the relationship between the ratio determined in step (b) and the pre-determined baseline threshold set forth in step (c). 
     
     
         14 . The in vitro method according to  claim 12 , wherein said at least one other group of T cells comprises Th17 cells.